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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; RESURFACING FEMUR, SIZE 3, RIGHT
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ONKOS SURGICAL ELEOS; RESURFACING FEMUR, SIZE 3, RIGHT Back to Search Results
Model Number 2500R003E
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 06/25/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device will not be returned for investigation as it remains implanted.The investigation is in progress.When the investigation is complete, a supplemental report will be submitted accordingly.Multiple mdrs were reported for this event: #3013450937-2021-00150.#3013450937-2021-00151.#3013450937-2021-00152.#3013450937-2021-00154.#3013450937-2021-00155.
 
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021 due to an alleged infection.The following parts were removed and revised: resurfacing femur axial pin, tibial hinge component, tibial poly spacer.The following parts remain implanted from the original eleos surgery which took place on (b)(6) 2021: resurfacing femur, cemented stem extension, and tibial baseplate.The surgeon removed implants with poly comopents and performed a washout.No further information was made available.
 
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021 due to an alleged infection.The following parts were removed and revised: resurfacing femur axial pin, tibial hinge component, tibial poly spacer.The following parts remain implanted from the original eleos surgery which took place on (b)(6) 2021: resurfacing femur, cemented stem extension, and tibial baseplate.The surgeon removed implants with poly components and performed a washout.No further information was made available.
 
Additional Manufacturer Narrative
This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.The root cause of the patient undergoing a revision surgery due to an alleged infection could not be determined.The device history records and sterilization batch records were reviewed and no issues during manufacturing or sterilization were identified that could have contributed to this complaint.If any additional information is obtained, a supplemental mdr will be filed accordingly.
 
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Brand Name
ELEOS
Common Device Name
RESURFACING FEMUR, SIZE 3, RIGHT
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany NJ 07054
MDR Report Key12189531
Report Number3013450937-2021-00153
Device Sequence Number5244575
Product Code KRO
UDI-Device IdentifierB2782500R003E0
UDI-PublicB2782500R003E0
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
K161520
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 09/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date05/02/2026
Device Model Number2500R003E
Device Catalogue Number2500R003E
Device Lot Number1751251
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/24/2021
Supplement Date Received by Manufacturer09/07/2021
Initial Report FDA Received Date07/19/2021
Supplement Report FDA Received Date09/07/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
P/N 25001212E, ELEOS TIBIAL POLY SPACER; P/N 25002113E, ELEOS RESURFACING FEMUR AXIAL PIN; P/N 25002204E, ELEOS TIBIAL BASEPLATE; P/N KSC14100E, ELEOS STEM EXTENSION, CEMENTED; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT; P/N 25001212E, ELEOS TIBIAL POLY SPACER; P/N 25002113E, ELEOS RESURFACING FEMUR AXIAL PIN; P/N 25002204E, ELEOS TIBIAL BASEPLATE; P/N KSC14100E, ELEOS STEM EXTENSION, CEMENTED; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age59 YR
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